# FDA recall Z-1034-2026

> **IMRIS Imaging Inc** · Class II · device recall initiated 2025-12-08.

## Product

Brand Name: HFD100  Product Name: Head Fixation Device HFD100  Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600  Software Version: Not Applicable  Product Description: The HFD100 Head Fixation Device provides rigid skeletal fixation within the optimal imaging envelope while  introducing minimal artifacts in the acquired images. There are two different assemblies for the HFD100. The standard HFD100 is equipped with a table adapter for use with either the operating room table or the angiography table. For sites with a Hill-Rom TruSystem 7500 Hybrid Neuro MR Operating Table (ORT400), the HFD100 has a split block clamp assembly (Trumpf Mount Clamp Assembly) which connects directly to the table back section. The HFD100 system is also comprised of the linkage components to mount the skull clamp to the table adapter, and the 3-pin skull clamp. The linkage system is used to position the skull clamp in the necessary position, without colli

## Reason for recall

Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.

## Key facts

- **Recall number:** Z-1034-2026
- **Recalling firm:** IMRIS Imaging Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-08
- **Report date:** 2026-01-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chaska, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1034-2026

## Citation

> AI Analytics. FDA recall Z-1034-2026. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-1034-2026. Source: US FDA. Licensed CC0.

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